The following data is part of a premarket notification filed by Cardio Metrics, Inc. with the FDA for Stableline.
| Device ID | K860298 |
| 510k Number | K860298 |
| Device Name: | STABLELINE |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | CARDIO METRICS, INC. 10415 LANDSBURY DR. Houston, TX 77099 |
| Contact | Mary K Noonen |
| Correspondent | Mary K Noonen CARDIO METRICS, INC. 10415 LANDSBURY DR. Houston, TX 77099 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-04-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STABLELINE 78745256 3140736 Dead/Cancelled |
MILLER MANUFACTURING COMPANY 2005-11-02 |